Job Description

The function of the Sr. Biostatistician is to supervise and to perform statistical analyses of data generated in clinical experiments, to advise in study design and interpretation of study results. Biostatistician II reviews/contributes to the development of the statistical analysis plans SAP ; counsels sponsors of Pharma Medica Research Inc PMRI in data collection, analysis and presentation for Phase I-IV clinical studies as necessary. Position reports to the VP, Scientific Affairs.

Duties and Responsibilities

Duties include, but are not necessarily limited to:

1. Develops methods/procedures to optimize study designs.

2. Provides advice for sample size requirements, dosing schemes and data analysis.

3. Reviews and provides recommendations for the statistical analysis sections of protocols and study reports.

4. Reviews and contributes to the development of statistical/data analysis plans SAP/DAP .

5. Generate and/or verifies randomization schemes as required.

6. Perform and/or verifies statistical analysis of data generated in Phase I-IV clinical trials.

7. Create new and/or improve old SAS programs use to perform data analysis, generate listings, tabulations, graphical presentations and summary statistics to support regulatory submissions.

8. Assist in validating existing SAS programs for Phase I-IV and BA/BE studies.

9. Counsels clients and PMRI personnel on statistical issues.

10. Advise Clinical Management Group in the development of electronic CRF and database required for Phase I-IV clinical trials.

11. Participate in the development, implementation, and maintenance of the Standard Operation Procedures SOPs related to statistical services.

12. Attend selected scientific and commercial meetings and exhibitions to assist in marketing of PMRI services.

13. Other duties as required. Health Safety Duties and Responsibilities All employees shall work according to the applicable provisions set out in the Occupational Health Safety Act section 28 , in addition to all health safety policies and procedures as set out by PMRI.

Working Conditions Work at PMRI s Head Office with minimal physical effort. Uses computer to perform data analyses.

Job Knowledge Minimum level of academic training or formalized training and work experience:

• Master degree in Mathematics and/or Statistics Advanced SAS programming skills
• Minimum amount of practical work experience: 2 year of experience in biostatistical area
• Must have excellent computer skills Other Requirements Excellent verbal and written English communication skills
• JOB DESCRIPTION SUMMARY: SR. BIOSTATISTICIAN cont d Ability to work both independently and as a team member Good interpersonal skills Excellent organizational skills Accountability Complete assigned tasks thoroughly and accurately within agreed time frames.